WHO PQT 在 ePQS 门户启用 eCTD 提交，新申请自 2027 年 9 月 30 日起强制使用
WHO PQT launches eCTD submissions through the ePQS Portal
WHO 预认证单位（PQT）已在 ePQS 门户启用 eCTD 提交功能，目前处于自愿采用阶段。对所有新申请的强制 eCTD 提交自 2027 年 9 月 30 日开始。PQT 称 eCTD 是全球统一的电子监管申报格式，将改善档案生命周期管理并简化审评流程，并提供指南文件、技术规范、FAQ 和培训材料支持申请人过渡。
材料说明 WHO 预认证的 eCTD 提交分阶段推行，并给出新申请强制提交的时间点，便于申请人安排资料准备节奏。
News
1 October, 2026 - 08:00 (CEST)
Announcement
The WHO Prequalification Unit (PQT) has launched eCTD submission capability through the ePQS Portal. The eCTD is a globally harmonized format for electronic regulatory submissions that will improve dossier lifecycle management and streamline the assessment process.
PQT is implementing the transition in phases, with voluntary adoption currently underway and mandatory eCTD submission for all new applications starting on 30 September 2027. Guidance documents, technical specifications, FAQs, and training materials are available to support applicants in the transition to eCTD.
来源：WHO 药品预认证与检查动态 · extranet.who.int